Blood-based products such as for example erythrocyte concentrates, thrombocyte concentrates, granulocyte concentrates, leukocyte concentrates, whole blood reserves or blood plasma reserves, are today used to a large extent in hospitals in the form of blood reserves. The obtainment of concentrates from human blood donors for transfusion is a complex process. Under ideal storage conditions at a temperature of between 2° C. and 6° C., the storage life of the reserves with erythrocyte concentrate is for example 42 days. Typically up to now, thrombocyte reserves have had to be discarded after a shorter time period.
The quality controlling of blood-based products is often carried out by corresponding confirmations from specialist personnel that a cold chain has been maintained. Since an interruption of the cold chain cannot be excluded in many cases, which can significantly reduce the duration of the storage life, reserves for which it cannot be safely determined whether the cold chain has been maintained uninterrupted are likely also discarded for safety reasons even before the expiration date is reached. It may also be the case that the blood donors carry germs or negative factors which were not visible or measurable at the time of the blood donation.
An objective quality control is desired. According to the corresponding guidelines, at least 2·1011 thrombocytes and less than 1 million leukocytes or 3 million residual erythrocytes should be contained for example in a thrombocyte concentrate. The pH value of a thrombocyte concentrate should be between 6.4 and 7.8. The product must be sterile until the end of the maximum storage life.
Compliance with these guidelines can be quantitatively verified. To this end, counts of the thrombocytes, erythrocytes and leukocytes can for example be carried out in processes using microscopes.
Conventional methods for the quantitative quality controlling of blood-based products, in which for example the thrombocyte count, the erythrocyte count, the protein content, the pH value and/or the calcium content is determined, are time-consuming and expensive, in particular because these samples may no longer be used for transfusion. According to the hemotherapy directive of the German Medical Association (as of 2010), 1% of all blood-based products, but at least 4 bags must be withheld for quality controlling. A proportion of 0.4·√n of the products must be verified when verifying the sterility and is thus also not suitable for use.
Furthermore, conventional methods provide no information or only very limited information regarding the functionality of the cells contained in the blood-based product. The functionality state or the storage life duration of the blood-based products could also be connected to the condition or state of the donor. Donor-specific possibilities for quality testing are not known at present.